Surgical Correction of Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title: OPEN SURGERY VS LAPAROSCOPY IN SURGERY OF PELVIC ORGAN PROLAPSE

Status Completed

Clinical Trial Summary

Objective:

This prospective randomized trial evaluated outcomes of colposacropexy performed either by open or by conventional laparoscopic approach as therapy for uterovaginal prolapse. Surgical techniques, efficacy and overall results are compared.

Methods:

In this prospective study 40 consecutive patients with uro-genital prolapse are randomized to sacropexy: 20 by an open approach, 20 by a conventional laparoscopy approach. Anchorage is achieved in both groups by two polypropylene meshes.

Check-ups were scheduled at 3, 6, 12 months and then yearly. Pre-operative patient characteristics, operative and post-operative events and follow-up results are recorded.

Clinical Trial Description

Surgical technique In both open or laparoscopic approach the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area of at least 3 x 5 cms where the mesh will be attached with four-five Polyglycolic 0 sutures. The procedure is repeated for the posterior vaginal wall, where the mesh will be attached with three-four Polyglycolic 0 sutures.

The sacral promontory surface is prepared and 1 or 2 non-reabsorbable 0.0 sutures are placed into the sacral periosteum about 2 cm below the promontory. A sub-peritoneal tunnel is created through which meshes are passed avoiding traction to the sacrum. The peritoneum is closed over the meshes. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

• NCT number: NCT01182090
• Study type: Interventional
• Source: University Of Perugia
• Status: Completed
• Phase: Phase 3
• Start date: August 2010
• Completion date: September 2012